Diabetes
Conditions
Brief summary
The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C\>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada. The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.
Detailed description
This study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. Consenting patients will be randomized to a Standard Pre-Operative Diabetes Care Group (Group 1) and a Structured Pre-Operative Diabetes Optimization Group (Group 2).
Interventions
OTHERStructured Pre-operative Diabetes Optimization
Patients will receive structured pre-operative diabetes optimization while they wait for surgery. Patients will be referred to the Youville Diabetes Center where they will undergo preoperative optimization of their diabetes management. This will include in-depth diabetes education and instruction pertaining to lifestyle modification (blood glucose monitoring, nutrition, and physical activity) to improve glycemic control. Pharmacologic therapy will be reviewed by the Youville Diabetes Center certified diabetes nurse educators.
Sponsors
Dr. Rakesh C. Arora
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to speak and understand English * Age \> 18 * Able to provide informed consent * A1C\>7% * Placed on the waiting list for elective cardiac surgery in Manitoba
Exclusion criteria
* Progressive cognitive deficit or disease. * Age \< 18 * Unable to provide informed consent * A1C\<7% * Undergoing emergent cardiac surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in A1C over the study period. | Baseline to the patients' 3-months post-operative appointment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes to the responses on the validated patient surveys | Baseline to the patients' 3-months post-operative appointment | Surveys: Audit of Diabetes Quality of Life, Diabetes Treatment Satisfaction Questionnaire, and the SF-12 Health Related Quality of Life Questionnaire, Patient Health Questionnaire-9. |
| Changes in the patient perioperative outcomes | Baseline to the patients' 3-months post-operative appointment | Surveys: Audit of Diabetes Quality of Life, Diabetes Treatment Satisfaction Questionnaire, and the SF-12 Health Related Quality of Life Questionnaire, Patient Health Questionnaire-9. |
Countries
Canada
Outcome results
None listed